When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Accountability
Supporting Activities
Site Activation Leadership and Strategy
- Lead site activation planning and strategy development for assigned clinical studies
- Oversee site activation milestones and deliverables to ensure timely and quality study start-up from site feasibility through last site activation
- Monitor and report on site activation progress across multiple studies and mitigate potential delays or risks
- Lead cross-functional teams to resolve complex site activation challenges and issues
- Develop, coordinate, and execute the study critical path plan. This includes but is not limited to Site Feasibility, Site Selection, Regulatory Green Light, Site Initiation, and Site Activation, as well as System Set-up, pertinent TMF/EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Site Activation Requirements & Relevant Tools, Documents, and Reporting
Team Leadership and Stakeholder Management
- Provide guidance to site activation team members
- Serve as liaison between project management, site start-up teams, and site activation functions
- Lead regular communication with internal teams regarding site activation status and actions
- Coordinate with clinical operations leadership to align site activation activities with overall study objectives
- Manage client relationships and communication regarding site activation timelines and deliverables
Client Relationship Management and Business Development
- Serve as the Study Start-Up (SSU) Subject Matter Expert (SME) for designated client accounts, providing strategic guidance, best practice recommendations, and technical expertise to ensure optimal study initiation and site activation outcomes
- Support business development activities by providing site activation expertise in proposals and bid pursuit meetings (BPMs)
Process Development and Quality Leadership
- Implementation of standardized site activation processes and best practices across studies
- Analyze site activation metrics and drive process optimization initiatives
- Ensure compliance with regulatory requirements and company SOPs during site activation
- Contribute to the development and maintenance of site activation procedures and templates
- Champion quality initiatives to enhance site activation efficiency and effectiveness
System Leadership and Strategic Documentation
- Lead utilization of CTMS, EDC, IXRS, and TMF systems to optimize site activation workflows
- Oversee accurate documentation of site activation processes and outcomes across studies
- Drive project planning system optimization related to site activation timelines and resource allocation
- Ensure proper data integrity and system maintenance for assigned portfolio
- Generate strategic reports and metrics using clinical trial management systems for leadership review
Skills:
- Excellent proficiency with CTMS, EDC, IXRS, and TMF systems
- Strong project planning and management software
- Comprehensive knowledge of clinical trial regulations and Good Clinical Practice
- Deep understanding of site activation processes and requirements
- Extensive familiarity with clinical research operations and workflows
- Advanced project management and strategic planning abilities
- Excellent written and verbal communication skills with senior stakeholders
- Strong management capabilities
- Excellent problem-solving and critical thinking skills
- Attention to detail and accuracy in complex documentation
- Excellent time management and ability to prioritize multiple complex projects
- Cross-functional leadership and coordination
- Change management and process improvement expertise
- Client relationship management and business development support
Knowledge and Experience:
- 4-7 years of experience in clinical research operations with site activation leadership
- Proven experience leading site activation teams and processes
- Comprehensive knowledge of clinical trial start-up processes and requirements
- Strong background in regulatory compliance in clinical research
- Extensive experience working with clinical research sites and investigators
- Demonstrated understanding of clinical trial timelines and milestone management
- Experience with process improvement and team leadership
Education:
- Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field
- Advanced training and experience in clinical operations, site management, and/or project management preferred